Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05437120
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2022-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, D-IVA, and Relevant Metabolites', 'timeFrame': 'Cohort 1: Pre-dose up to Day 23; Cohort 2: Pre-dose up to Day 13'}, {'measure': 'Area Under the Concentration Versus Time Curve (AUC) of VX-121,TEZ, D-IVA, and Relevant Metabolites', 'timeFrame': 'Cohort 1: Pre-dose up to Day 23; Cohort 2: Pre-Dose up to Day 13'}, {'measure': 'Fraction Unbound (fu) for VX-121 and D-IVA in Plasma', 'timeFrame': 'Cohorts 1 and 2: Pre-dose up to Day 2'}, {'measure': 'Unbound Maximum Observed Concentration (Cmax ub) for VX-121 and D-IVA', 'timeFrame': 'Cohorts 1 and 2: Pre-dose up to Day 2'}, {'measure': 'Unbound Area Under the Concentration Versus Time Curve (AUC ub) of VX-121 and D-IVA', 'timeFrame': 'Cohorts 1 and 2: Pre-dose up to Day 2'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Cohort 1: Day 1 up to Day 32; Cohort 2: Day 1 up to Day 17'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.', 'detailedDescription': 'This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Cohort 1: Participants with Moderate Hepatic Impairment\n\n * Participants will satisfy the criteria for moderate hepatic impairment defined as a Child-Pugh total score of 7 to 9 points at the screening visit\n * Participants will have chronic (≥6 months) documented liver disease\n* Cohort 2: Matched Healthy Participants\n\n * Participants will be matched during screening to participants with hepatic impairment for cigarette smoking habit, age, sex, and weight\n\nKey Exclusion Criteria:\n\n* Cohort 1: Participants with Moderate Hepatic Impairment\n\n * History of febrile illness or other acute illness\n * History of solid organ or bone marrow transplantation\n * History or presence of severe hepatic encephalopathy (Grade \\>2)\n * Any condition possibly affecting drug absorption\n * Severe portal hypertension\n * Significant renal dysfunction (creatinine clearance \\<50 milliliter per minute \\[mL/min\\] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1\n* Cohort 2: Matched Healthy Participants\n\n * History of febrile illness or other acute illness\n * Any condition possibly affecting drug absorption\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05437120', 'briefTitle': 'Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of a Single Dose of VX-121/Tezacaftor/Deutivacaftor in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects', 'orgStudyIdInfo': {'id': 'VX21-121-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment will receive single dose of VX-121/TEZ/D-IVA .', 'interventionNames': ['Drug: VX-121/TEZ/D-IVA']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Matched Healthy Participants', 'description': 'Healthy participants will receive single dose of VX-121/TEZ/D-IVA.', 'interventionNames': ['Drug: VX-121/TEZ/D-IVA']}], 'interventions': [{'name': 'VX-121/TEZ/D-IVA', 'type': 'DRUG', 'otherNames': ['VX-121/VX-661/VX-561', 'VX-121/VX-661/CTP-656', 'VX-121/tezacaftor/deutivacaftor'], 'description': 'Fixed-dose combination tablets for oral administration.', 'armGroupLabels': ['Cohort 1: Moderate Hepatic Impairment', 'Cohort 2: Matched Healthy Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014-3616', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'GCP Research', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}